Entry Detail
| General information | |
| Database: | DB00110 |
| Objective: | to assess the safety of the multikinase inhibitor regorafenib in patients with hepatocellular carcinoma (hepatocellular carcinoma) that had progressed following firstline sorafenib. |
| Authors: | Bruix J, et al |
| Title: | Regorafenib as secondline therapy for intermediate or advanced hepatocellular carcinoma: multicenter, openlabel, phase II safety study. |
| Journal: | Eur J Cancer. |
| Year: | 2013 |
| PMID: | 23809766 |
| Trial Design | |
| Clinical Trial Id: | NCT01003015 |
| Agent: | regorafenib |
| Target: | Protooncogene tyrosineprotein kinase receptor ret Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Vascular endothelial growth factor receptor 3 |
| Cancer Type: | liver cancer |
| Cancer Subtype: | hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a multicentre, openlabel, phase II safety study. |
| Key Patients Feature: | patients with Barcelona Clinic Liver Cancer stage B or C hepatocellular carcinoma and preserved to mildly impaired liver function (ChildPugh class A) at 13 centres in Europe and Asia |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received regorafenib 160 mg once daily in cycles of 3 weeks on/1 week off treatment until disease progression, unacceptable toxicity, death or patient/physician decision to discontinue. |
| Primary End Point: | safety |
| Secondary End Point: | efficacy (including time to progression and overall survival). |
| Patients Number: | 36 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | The median treatment duration was 19.5 weeks (range 2103). At data cutoff, 3 patients remained on treatment. Reasons for discontinuation were adverse events (n=20), disease progression (n=10), consent withdrawal (n=2) and death (n=1). 17 patients required dose reductions (mostly for adverse events [n=15]); 35 patients had treatment interruption (mostly for adverse events [n=32] or patient error [n=11]). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median time to progression was 4.3 months |
| Median OS A vs. C: | Median overall survival was 13.8 months. |
| Adverse Event(agent arm): | The most frequent treatmentrelated adverse events were handfoot skin reaction (any grade n=19; grade more than and equal to 3 n=5), diarrhoea (n=19; n=2), fatigue (n=19; n=6), hypothyroidism (n=15; n=0), anorexia (n=13; n=0), hypertension (n=13; n=1), nausea (n=12; n=0) and voice changes (n=10; n=0). |
| Conclusions: | Regorafenib had acceptable tolerability and evidence of antitumour activity in patients with intermediate or advanced hepatocellular carcinoma that progressed following firstline sorafenib. |